The Efficacy and Safety of Palonosetron in Preventing the Gastrointestinal Reactions Induced by 3-day Highly Emetogenic Chemotherapy

NCT01909856 | Completed Phase 2

• 1 other identifier: sim-palonosetron
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to assess the efficacy and safety of palonosetron in preventing the acute and delayed emesis induced by 3-day highly emetogenic chemotherapy. A double-blind, crossover design is used and granisetron is the positive control.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Complete Response(CR) within 24-120 hours after chemotherapy

  24-120 hours

Secondary Outcomes (3)

• CR within 0-120 hours after chemotherapy

  0-120 hours

• CR within 0-24 hours after chemotherapy

  0-24 hours

• Incidence of Adverse events

  up to 3 months

Study Arms (2)

Arm1

EXPERIMENTAL

1st cycle Palonosetron, 2nd cycle Granisetron

Drug: Palonosetron; Drug: Granisetron; Drug: Dexamethasone; Drug: Cisplatin

Arm2

EXPERIMENTAL

1st cycle Granisetron, 2nd cycle Palonosetron

Drug: Palonosetron; Drug: Granisetron; Drug: Dexamethasone; Drug: Cisplatin

Interventions

Palonosetron DRUG

Palonosetron 0.25mg d1,d3

Arm1; Arm2

Granisetron DRUG

Granisetron 3mg d1-3

Arm1; Arm2

Dexamethasone DRUG

Dexamethasone 10mg d1-3

Arm1; Arm2

Cisplatin DRUG

3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3

Arm1; Arm2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with malignant tumors who can receive 3-day chemotherapy regimens defined by the protocol;
• The two-cycle sequential chemotherapy must be the same in drugs, dosage, sequence and routes of administration;
• Patients are prohibited from any other chemotherapy drugs during the study, as well as other antiemesis, sedative and psychotropic drugs within 5 days after chemotherapy;
• Life expectancy ≥ 3 months;
• Adequate hematologic function;
• Adequate hepatic function;
• Adequate renal function;
• At least 2 weeks away from the last chemotherapy;
• Patients signed written informed consent.

You may not qualify if:

• Pregnant or lactating women;
• History of anticipatory vomiting;
• Radiation therapy on the abdomen or pelvis within one week prior to study entry;
• Concomitant use of other drugs which may affect the antiemetic effects (such as omeprazole, amifostine, etc.);
• Patients with gastrointestinal obstruction;
• Patients with severe heart disease, liver or renal disease, or metabolism disorders;
• Patients with epilepsy or using sedative or psychotropic drugs;
• Patients with diabetes or with contraindication for corticosteroids;
• Patients who received antiemetic drugs or experienced nausea or vomiting within 24 hours prior to study entry;
• Patients with brain metastasis or intracranial hypertension;
• Hypersensitivity to 5-HT3 receptor antagonist;
• Patients with active infection;
• Other conditions that the investigator considered as unsuitable for chemotherapy;
• Subjects participating in other clinical trials.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Tongji Hospital,Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Palonosetron; Granisetron; Dexamethasone; Cisplatin

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Bridged Bicyclo Compounds, Heterocyclic; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Shiying Yu, MD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 29, 2013
• Study Start: October 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 4, 2015

Record last verified: 2015-11

Locations

CN (1)